Real-World Safety Comparison of Alfuzosin Prolonged Release Versus Traditional Immediate Release Alfuzosin in Indian Men With LUTS/BPH

Background

Alfuzosin, an α-blocker widely used for the management of benign prostatic hyperplasia (BPH)–associated lower urinary tract symptoms (LUTS), is known to cause dizziness and orthostatic hypotension, primarily due to high peak plasma concentrations. These adverse events can negatively impact tolerability, increase fall risk, and lead to treatment discontinuation—particularly in elderly patients and those with cardiovascular comorbidities.

Alfoo Advance, a newer Alfuzosin formulation with optimized pharmacokinetics and controlled drug release, is designed to reduce peak-related adverse effects while maintaining clinical efficacy. India-specific real-world evidence comparing its safety profile with traditional Alfuzosin formulations is currently limited.

Study Objective

To evaluate whether Alfoo Advance is associated with a lower incidence of clinically significant dizziness and orthostatic hypotension compared with traditional Alfuzosin formulations, using retrospective real-world data from Indian Electronic Medical Records (EMR).

Study Design and Data Source

• Design: Retrospective, observational cohort study
• Data Source: De-identified EMR data from Indian hospitals and urology practices
• Study Period: Past 12 months, with a minimum of 6-month follow-up
• Population: Men with LUTS/BPH newly initiated on Alfoo Advance or traditional Alfuzosin

Exposure and Comparator

• Index Date: First prescription of study drug
• Cohorts:
  • Alfoo Advance (optimized-PK formulation)
  • Traditional Alfuzosin formulation

Outcomes

Primary Outcome: Incidence of clinically significant dizziness or orthostatic hypotension within 6 months.

Secondary Outcomes: Falls and syncope, ER visits, hospitalizations, treatment discontinuation, safety in elderly/comorbid patients.

Analytical Approach

• Descriptive baseline comparisons
• Adjustment for confounding using propensity score methods
• Comparative incidence and risk analyses using regression models

Key Feasibility Considerations and Risks

• Challenge: Limited availability of traditional Alfuzosin patients.
• Mitigation: Multi-center inclusion, brand mapping, sensitivity analyses.

Strategic and Medical Value

• Provides India-specific real-world evidence on the safety profile of an optimized-PK Alfuzosin formulation
• Supports medical, regulatory, and scientific discussions
• Informs evidence-based positioning

Conclusion

This retrospective EMR-based study offers a feasible and clinically relevant approach to evaluating whether Alfoo Advance demonstrates improved tolerability over traditional Alfuzosin in real-world Indian practice.